Study of Oral Weekly Lepetegravir (Formerly GS-1720) and Lenacapavir Pacfosacil (Formerly GS-4182) Versus Biktarvy in People With HIV-1 Who Are Virologically Suppressed
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gilead Sciences
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Documented plasma HIV-1 RNA \< 50 copies/mL for ≥ 24 weeks before and at screening.
Receiving BVY for ≥ 24 weeks prior to screening.
You may not be if
Prior use of, or exposure to LEN, lepetegravir, or lenacapavir pacfosacil.
History of virologic failure while on an integrase strand-transfer inhibitor (INSTI)-based regimen.
Documented integrase strand-transfer inhibitor (INSTI) resistance, specifically, resistance-associated mutations (RAMs) E92G/Q, G118R, F121Y, Y143C/H/R, S147G, Q148H/K/R, N155H/S, or R263K in the integrase gene.
Prior use of any long-acting (LA) parenteral antiretrovirals (ARV) such as monoclonal antibodies (mAbs) or broadly neutralizing antibodies (bNAbs) targeting HIV-1, injectable cabotegravir (including oral cabotegravir lead-in), or injectable rilpivirine.
Any of the following laboratory values at screening:
* Clusters of differentiation 4 (CD4) cell count \< 200 cells/mm\^3 at screening
* Glomerular filtration rate \< 60 mL/min according to the Modification of Diet in Renal Disease formula
* Hepatic transaminases (aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \> 1.5 × upper limit of normal (ULN)
* Direct bilirubin \> 1.5 × ULN
* Platelets count \< 50,000 cells/mm\^3
* Hemoglobin \< 8.0 g/dL
Active or occult hepatitis B virus (HBV) infection.
Active hepatitis C virus (HCV).
Clareo Health | Study of Oral Weekly Lepetegravir (Formerly GS-1720) and Lenacapavir Pacfosacil (Formerly GS-4182) Versus Biktarvy in People With HIV-1 Who Are Virologically Suppressed
